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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K252984
Device Name Perin Health System (PHD80060-2)
Applicant
Perin Health Devices, LLC
755 Research Pkwy.
Oklahoma City,  OK  73104
Applicant Contact Ian McLane
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy., Suite 800
Dunwoody,  GA  30338
Correspondent Contact Tyler Ting
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
BZQ   DQA   DQD   DXN   FLL  
MHX  
Date Received09/18/2025
Decision Date 01/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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